Physicochemical stability assessment of all-in-one parenteral emulsion for neonates containing SMOFlipid

Skouroliakou, Maria; Kountouri, Aggeliki M.; Hatziantoniou, Sophia; Koutri, Katerina; Chiou, Antonia

doi:10.1136/ejhpharm-2012-000121

Cited by 5 publications

(9 citation statements)

References 30 publications

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“…17 Lecithin was chosen as the main surfactant due to its safety reputation, and they are currently used in commercial lipid emulsions. [18][19][20] Furthermore, lecithin as a naturally occurring phospholipid derived from soybean contains a phospholipid and acetylcholine that was demonstrated to have a profound effect on brain function. The percentage of lecithin used in nanoemulsion productions was kept in a permitted concentration of 3.00% (w/w).…”

Section: Fabrication Of Clnmentioning

confidence: 99%

Development of nanoemulsion for efficient brain parenteral delivery of cefuroxime: designs, characterizations, and pharmacokinetics

Harun¹,

Nordin²,

Gani³

et al. 2018

IJN

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Background and aimDrugs that are effective against diseases in the central nervous system and reach the brain via blood must pass through the blood–brain barrier (BBB), a unique interface that protects against potential harmful molecules. This presents a major challenge in neuro-drug delivery. This study attempts to fabricate the cefuroxime-loaded nanoemulsion (CLN) to increase drug penetration into the brain when parenterally administered.MethodsThe nanoemulsions were formulated using a high-pressure homogenization technique and were characterized for their physicochemical properties.ResultsThe characterizations revealed a particle size of 100.32±0.75 nm, polydispersity index of 0.18±0.01, zeta potential of −46.9±1.39 mV, viscosity of 1.24±0.34 cps, and osmolality of 285.33±0.58 mOsm/kg, indicating that the nanoemulsion has compatibility for parenteral application. CLN was physicochemically stable within 6 months of storage at 4°C, and the transmission electron microscopy revealed that the CLN droplets were almost spherical in shape. The in vitro release of CLN profile followed a sustained release pattern. The pharmacokinetic profile of CLN showed a significantly higher Cmax, area under the curve (AUC)0–t, prolonged half-life, and lower total plasma clearance, indicating that the systemic concentration of cefuroxime was higher in CLN-treated rats as compared to cefuroxime-free treated rats. A similar profile was obtained for the biodistribution of cefuroxime in the brain, in which CLN showed a significantly higher Cmax, AUC0–t, prolonged half-life, and lower clearance as compared to free cefuroxime solution.ConclusionOverall, CLN showed excellent physicochemical properties, fulfilled the requirements for parenteral administration, and presented improved in vivo pharmacokinetic profile, which reflected its practical approach to enhance cefuroxime delivery to the brain.

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Section: Fabrication Of Clnmentioning

confidence: 99%

Development of nanoemulsion for efficient brain parenteral delivery of cefuroxime: designs, characterizations, and pharmacokinetics

Harun¹,

Nordin²,

Gani³

et al. 2018

IJN

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“…[ 8 ] Therefore, the pH value of PN in a range 5–6 indicates the stability; in contrast, the pH that is less than 5 specifies free fatty acid formation being followed with larger globule. [ 8 9 ]…”

Section: Discussionmentioning

confidence: 99%

Provision of Standardized All-in-One Parenteral Nutrition (AIO-PN) for Very Preterm Neonates

Hanifah

Maulidani

Nugroho

et al. 2021

Journal of Pharmacy and Bioallied Sciences

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A BSTRACT Introduction: All-in-one parenteral nutrition (AIO-PN) is essential for patients with limited venous access, e.g. premature infants. So far, there are still some conflicting data related to the stability of AIO-PN. The aim of this study is to examine the physical stability and sterility of AIO-PN as it was being stored at room and cold temperature. Materials and Methods: AIO-PN contains dextrose, amino acid, lipid, sodium chloride, magnesium sulfate, potassium chloride, calcium gluconate, and vitamin. Formulation of AIO-PN was prepared based on the guidance of nutrition for 3-day-old preterm baby weighing 1000 g. The formulation of AIO-PN then was stored at room temperature (25.43ºC ± 0.54) and cold temperature (6.2ºC ± 2.04). Results and Discussion: Based on the experiments, all formulas confidently fulfilled the sterile criteria, in which there is no microbial growth in the formula within 7 days. During those days, the droplet size of all formulas was under the range (<500 nm) with a good range of pH. However, during the process of storing under the room temperature, AIO-PN showed the reversible creaming starting on day 2 and the discoloration starting on day 4. Meanwhile, we found that there are no such physical changes in the formula within 7 days under the cold temperature. Conclusion: This research confirmed that AIO-PN that is being stored at room temperature cannot be used starting on day 4, but the formulation storage under the cold temperature is still accepted within 7 days.

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“…The final volume of all PN admixtures was adequate to maintain the fluid requirements of preterm neonates. All PN admixtures were protected from light by covering the bags with aluminum foil to prevent vitamin loss and lipid peroxidation 6,8 . Stability assessment of the prepared PN admixtures was carried out immediately after preparation (t = 0 hour) and after 24 hours of storage at 25 °C (room temperature) and at 37 °C.…”

Section: Methodsmentioning

confidence: 99%

“…Therefore, ILEs are often administered to neonates via a Y connection, to be separated from other components of PN admixtures (ie, 2‐in‐1 PN admixtures) 2 . This issue was addressed in a few studies that investigated the stability of 4‐oil ILE in concentrated PN admixtures and consequently recommended their administration to preterm neonates 6‐8 . Nevertheless, no previous studies have evaluated the clinical safety and efficacy of PN admixtures containing 4‐oil ILE in preterm neonates.…”

Section: Introductionmentioning

confidence: 99%

Stability Study and Clinical Evaluation of Lipid Injectable Emulsion in Parenteral Nutrition Admixtures Used for Preterm Neonates

et al. 2020

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Background Intravenous administration of parenteral nutrition (PN) admixtures containing 4‐oil lipid injectable emulsion (ILE) in preterm neonates is usually prohibited because of limited clinical data. The authors evaluated the stability, safety, and efficacy of PN admixtures containing 4‐oil ILE, for the first time, in preterm neonates. Methods A series of PN admixtures were prepared for consecutive administration in preterm neonates over a period of 15 days. Admixture stability was assessed after 24 hours of storage at 25 and 37 °C via visual inspection and measurement of mean droplet size (MDS). Safety and efficacy of the admixtures in preterm neonates were assessed via serum triglyceride levels and body weight increase measurements, respectively. Results PN admixtures were stable at 25 °C and had MDS ˂500 nm. After 15 days, there was a significant increase in body weight (P ≤ .0001) and level of serum triglycerides (P ≤ .0001), compared with the level before PN administration. Conclusions PN admixtures containing 4‐oil ILE were stable at 25 °C and showed instability at 37 °C. Therefore, it is recommended to keep the temperature during administration of PN admixtures at 25 °C. PN admixtures were well tolerated and safe over a period of 8 days while providing a balanced fatty acid supply. Tight monitoring of serum triglyceride level is essential, particularly in neonates of low birth weight and/or young gestational age, to avoid hypertriglyceridemia. Hence, the use of these PN admixtures is expected to be beneficial in terms of being cost‐effective and reducing the contamination risks.

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Physicochemical stability assessment of all-in-one parenteral emulsion for neonates containing SMOFlipid

Cited by 5 publications

References 30 publications

Development of nanoemulsion for efficient brain parenteral delivery of cefuroxime: designs, characterizations, and pharmacokinetics

Development of nanoemulsion for efficient brain parenteral delivery of cefuroxime: designs, characterizations, and pharmacokinetics

Provision of Standardized All-in-One Parenteral Nutrition (AIO-PN) for Very Preterm Neonates

Stability Study and Clinical Evaluation of Lipid Injectable Emulsion in Parenteral Nutrition Admixtures Used for Preterm Neonates

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